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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE Communicator

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 Class 2 Recall
LATITUDE Communicator
see related information
Date Posted November 12, 2009
Recall Status1 Terminated on December 04, 2012
Recall Number Z-0180-2010
Recall Event ID 53083
Premarket Approval
PMA Number
P910077/S092
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Guidant LATITUDE® Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE® Patient Management system enables physicians to periodically monitor both patient and device status remotely. The LATITUDE® Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.
Code Information SERIAL NUMBERS: 029251, 064452, 059718, 064001, 056441, 059851, 070188, 072291, 312706, 305339, 312762, 004610, 024762, 049668, 061205, 067781, 051788, 056069, 068447, 069808, 008653, 068085, 057090, 023576, 028974, 017638, 603254, 064457, 069473, 069902, 071065, 072021, 073621, 073837, 312707, 605519, 603234, 603788, 072396, 059662, 056346, 301645, 312781, 307327, 067067, 055853, 060274, 605304, 305344, 302301, 605981, 009271, 056500, 300895, 602642, 030830, 301117, 055001, 049660, 047455, 056923, 309556, 044034, 063667, 005931, 067765, 063012, 050130, 051267, 055558, 060325, 060973, 063034, 306808, 306852, 309355, 041156, 062922, 063064, 061177, 300499, 039398, 039401, 039403, 060619, 065476, 058913, 056802, 073812 024833, 073560, 606104, 606288, 606604, 606826, 607180 608231 and 607180.
Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Manufacturer Reason
for Recall
The L ATITUDE¿ communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientific's servers. It
FDA Determined
Cause 2
DESIGN: Software Design
Action Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected. Notifications via phone calls to additional patients affected began on August 17, 2009. Direct questions about the recall to the LATITUDE Customer Service by calling 1-651-582-4000.
Quantity in Commerce 97
Distribution Nationwide Distribution -- AZ, AR, CA, CT, FL, GA, IL, IN, MA, MO, NV, NJ, NY, OH, OR, PA, SC, TX, UT, VA and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Applicant = GUIDANT CORP.
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